BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL+ DEFIBRILLATOR/MONITOR

    MDR report key: 3983913 · Received June 24, 2014

    Report

    Report Number
    1218950-2014-03641
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Report Date
    May 31, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K110825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS HEALTHCARE THAT THE HEARTSTART MRX FAILED OPCHECK FOR AN UNSPECIFIED ISSUE. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368484 HEARTSTART XL+ DEFIBRILLATOR/MONITOR MKJ PHILIPS MEDICAL SYSTEMS 861290

    Patients

    Seq Age Sex Outcome Treatment
    1